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NCT Number: NCT07222683

The Impact of Renal Transplant on Coronary Microvascular Function Among Patients With Advanced Chronic Kidney Disease

People with chronic kidney disease (CKD) often experience faster aging of the heart and blood vessels, which raises the risk of heart problems beyond traditional factors like high blood pressure or cholesterol. One early sign is reduced blood flow in the tiny vessels that supply the heart, measured by a positron emission tomography (PET) scan using a marker called myocardial flow reserve (MFR). In CKD, ongoing inflammation and abnormal blood vessel growth can damage these small vessels, leading to heart stiffness and weaker heart function.

A kidney transplant offers a unique chance to study how better kidney function and reduced inflammation affect heart health. The observational RESTORE study ("Impact of Renal Transplant on Coronary Microvascular Function in Patients with Advanced CKD") will measure heart blood flow and function before and after transplant.

The study will test whether:

1. Inflammation and abnormal vessel growth are linked to poor heart blood flow and heart function in CKD. 2. Kidney transplant improves heart blood flow and function. 3. Lower inflammation after transplant leads to better heart health.

By understanding how kidney disease and inflammation affect the heart-and how transplant may reverse these effects-this research could help guide future treatments to better protect heart health in patients with CKD.

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Key information

Conditions

Chronic Kidney Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chronic Disease Coronary Artery Disease Coronary Disease Coronary Microvascular Dysfunction (CMD) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Inflammation Kidney Diseases Kidney Transplant Male Urogenital Diseases Myocardial Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Daniel M Huck, MD, MPH

CONTACT

[email protected]

8573074000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Renal transplant candidate on the waitlist
  • Age greater or equal to 45 years, or if 18-44 years of age on dialysis for 5 years or more

Exclusion criteria

  • Left ventricular ejection fraction (LVEF) < 40%
  • History of coronary artery bypass grafting (CABG)
  • History of heart transplant
  • Patients who undergo revascularization as a result of pre-transplant cardiac PET

Treatment and study plan

Primary outcomes

  1. Stress Myocardial Blood Flow (MBF)

    Time frame: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    Myocardial blood flow with hyperemic stress measured on PET myocardial perfusion imaging

  2. Myocardial Flow Reserve (MFR)

    Time frame: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    Ratio of stress and rest myocardial blood flow assessed by PET

  3. Left ventricular global longitudinal strain (GLS, %)

    Time frame: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    Left ventricular global longitudinal strain measured on echocardiography

  4. Left ventricular mitral inflow velocity to mitral annular early diastolic relaxation velocity ration (E/E')

    Time frame: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    E/E' measured by echocardiography

  5. Interleukin-6 (IL-6) levels

    Time frame: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    IL-6 levels measured via proteomics assays

  6. Vascular Endothelial Growth Factor A (VEGF-A)

    Time frame: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    VEGF-A measured by proteomic assay

  7. Angiopoeitin-1 (ANGPT1) Levels

    Time frame: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    ANGPT1 levels measured by proteomic assay

  8. Angiopoeitin-2 (ANGPT2) Levels

    Time frame: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    ANGPT2 levels measured by proteomics

Secondary outcomes

  1. Left ventricular ejection fraction (LVEF)

    Time frame: 1. Transplant Arm: At baseline prior to transplant and one year after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    LVEF by echocardiography

  2. High sensitivity c-reactive protein (hs-CRP)

    Time frame: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    hs-CRP measured by blood assay

  3. High-sensitivity Troponin

    Time frame: 1. Transplant Arm: At baseline prior to transplant, and 0, 2, 4, 6 and 12 months after transplant 2. Waitlist Control Arm: At baseline prior to transplant and one year after baseline while remaining on the transplant waitlist

    High-sensitivity troponin by blood assay

Study contacts

Contact information is provided by the study sponsor or research team.

Daniel M Huck, MD, MPH

CONTACT

[email protected]

8573074000

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • American Heart Association
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: RESTORE

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Oct 30, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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